BRAVES (sleeve gastrectomy vs. lifestyle modifications)
Trial question
What is the role of sleeve gastrectomy in patients with MASH?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
46.0% female
54.0% male
N = 192
192 patients (88 female, 104 male).
Inclusion criteria: patients with biopsy-proven MASH.
Key exclusion criteria: coronary event or procedure in the previous 6 months; liver cirrhosis; end-stage renal failure; pregnancy; substantial alcohol consumption; life-threatening non-cardiac disease; Wilson's disease.
Interventions
N=96 sleeve gastrectomy (resection of stomach with a residual gastric remnant capacity of 60-80 mL plus lifestyle modification counseling).
N=96 lifestyle modification (structured lifestyle intervention program including diet and physical activity plus best medical care).
Primary outcome
Proportion of patients achieving histological resolution of metabolic dysfunction-associated steatohepatitis without worsening of fibrosis at 1-year follow-up
57%
16%
57.0 %
42.8 %
28.5 %
14.3 %
0.0 %
Sleeve
gastrectomy
Lifestyle
modification
Significant
increase ▲
NNT = 2
Significant increase in the proportion of patients achieving histological resolution of MASH without worsening of fibrosis at 1-year follow-up (57% vs. 16%; RR 3.67, 95% CI 2.23 to 6.02).
Secondary outcomes
Significantly greater improvement of at least one stage of liver fibrosis without worsening of MASH (39% vs. 23%; RR 1.7, 95% CI 0.13 to 3.27).
No significant difference in worsening of fibrosis (8% vs. 16%; RR 0.47, 95% CI 0.19 to 1.17).
Significantly greater improvement of at least one point in NAFLD activity score at 1-year follow-up (97% vs. 51%; RR 1.9, 95% CI 1.53 to 2.36).
Safety outcomes
No significant differences in pain, fatigue, constipation, diarrhea.
Conclusion
In patients with biopsy-proven MASH, sleeve gastrectomy was superior to lifestyle modification with respect to the proportion of patients achieving histological resolution of MASH without worsening of fibrosis at 1-year follow-up.
Reference
Ornella Verrastro, Simona Panunzi, Lidia Castagneto-Gissey et al. Bariatric-metabolic surgery versus lifestyle intervention plus best medical care in non-alcoholic steatohepatitis (BRAVES): a multicentre, open-label, randomised trial. Lancet. 2023 May 27;401(10390):1786-1797.
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